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Taking people in ChinaPhase 3

Tests firmonertinib against standard drugs in lung cancer with rare EGFR mutations

Tests firmonertinib in adults with advanced lung cancer and rare EGFR mutations.

Plain-language title generated from the registry record
Registry title: Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

Key facts

Where
Beijing, Changsha, Chengdu, Chongqing, Dalian, Foshan, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Hohhot, Jinan, Kunming, Linyi, Luoyang, Nanchang, Nanjing, Nanning, Nantong, Qingdao, Shanghai, Shantou, Shenyang, Shijiazhuang, Taiyuan, Tianjin, Weifang, Wuhan, Xiamen, Xinxiang, Yibin, and Zhengzhou, ChinaSee the 48 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lung cancer (NSCLC) that has spread or cannot be treated by surgery or radiotherapy, and that has an uncommon EGFR PACC mutation. They must not have had treatment yet for advanced disease.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced or metastatic non-small cell lung cancer that cannot be cured by surgery or radiotherapy
Earlier treatment
No earlier systemic anticancer treatment for advanced disease, including any EGFR-targeting drug. Earlier treatment before surgery or after surgery for non-metastatic disease is allowed only if at least 12 months have passed without treatment.
Biomarker or test result
An EGFR PACC mutation from the record's list, found in tumor tissue or blood by local testing

Main reasons for not taking part

  • Earlier systemic anticancer treatment for advanced lung cancer
  • Earlier treatment with any EGFR-targeting drug, such as an EGFR TKI or antibody
  • Neo-adjuvant or adjuvant treatment for non-metastatic disease ended less than 12 months ago

Read by machine on 9 November 2026.

Where in China

  • Beijing chest hospital, Capital Medical UniversityBeijing, ChinaTaking people
  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
  • Peking University Cancer Hospital (PKUCH)/Beijing Cancer HospitalBeijing, ChinaTaking people
  • Peking University People's HospitalBeijing, ChinaTaking people
  • Hunan Cancer HospitalChangsha, ChinaTaking people
  • Profile of The Third Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • Sichuan Cancer HospitalChengdu, ChinaTaking people
  • West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • The Second Hospital of Dalian Medical UniversityDalian, ChinaTaking people
  • The First People's Hospital of FoshanFoshan, ChinaTaking people
  • Fujian Cancer HospitalFuzhou, ChinaTaking people
  • Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
  • The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
  • Zhejiang Cancer HospitalHangzhou, ChinaTaking people
  • Harbin Medical University Cancer HospitalHarbin, ChinaTaking people
  • Anhui Provincial HospitalHefei, ChinaTaking people
  • The Affiliated Hospital of Inner Mongolia Medical UniversityHohhot, ChinaTaking people
  • Jinan Central HospitalJinan, ChinaTaking people
  • Yunnan Cancer HospitalKunming, ChinaTaking people
  • LinYi Cancer HospitalLinyi, ChinaTaking people
  • The First Affiliated Hospital of Henan University of Science &TechnologyLuoyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • Jiangsu Province HospitalNanjing, ChinaTaking people
  • Nanjing Drum Tower hospitalNanjing, ChinaTaking people
  • Guangxi Medical University Cancer HospitalNanning, ChinaTaking people
  • Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
  • Shanghai Chest HospitalShanghai, ChinaTaking people
  • Shanghai Geriatric Medical CenterShanghai, ChinaTaking people
  • Shanghai Pulmonary HospitalShanghai, ChinaTaking people
  • Cancer Hospital of Shantou University Medical CollegeShantou, ChinaTaking people
  • Cancer hospital of Dalian university of technologyShenyang, ChinaTaking people
  • China shenyang the tenth People's HospitalShenyang, ChinaTaking people
  • The First Hospital of China Medical UniversityShenyang, ChinaTaking people
  • The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
  • Shanxi Cancer hospitalTaiyuan, ChinaTaking people
  • Tianjin Chest HospitalTianjin, ChinaTaking people
  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
  • Weifang People's HospitalWeifang, ChinaTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
  • Zhongshan Hospital Xiamen UniversityXiamen, ChinaTaking people
  • The First Affiliated Hospital of Henan Medical UniversityXinxiang, ChinaTaking people
  • Yibin Second People's HospitalYibin, ChinaTaking people
  • Henan Cancer CenterZhengzhou, ChinaTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
ArriVent BioPharma, Inc.
Trial code
NCT07185997
Record updated
2 November 2026
Original description
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.Read full original descriptionShow less

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.

Key Eligibility Criteria:; Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy; Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing; No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies); Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months; Patients with asymptomatic CNS metastases are eligible; List of eligible PACC mutations:; E709X, E709A, E709H, E709V, E709K E709_T710delinsD, E709_T710delinsA, E709_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740_K745dup, I740_K745dupIPVAIK, I744_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768_V769delinsIL, S768_V769delinsIM, S768_V769delinsPL, V769L, V769M, N771G, H773_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750_I759delinsPN, T751_I759delinsN.

ClinicalTrials.gov NCT07185997